Kornimate/medical-research-clean huggingface dataset:
effects of physical activity and dietary change in minority breast cancer survivors

Conditions: Breast Cancer

Summary: this study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of hispanic or african descent (n=45). this is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. participants in both groups will exercise at a neighborhood curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.


Eligibility criteria:
inclusion criteria: * 21-70 yrs * stage 0-iiia breast cancer * no evidence of recurrent/metastatic disease * hispanic or african descent (african-american or caribbean) * bmi \> 25kg/m2 * sedentary * completed surgery, chemotherapy, and radiation therapy ≥ 6 months * blood pressure \< 140/90 * hgba1c \< 8 * ldl cholesterol \< 150 * no uncontrolled comorbidities * vo2 max normal ekg changes * non-smoker exclusion criteria: * evidence of recurrent or metastatic breast cancer * uncontrolled co-morbid illness including, but not limited to, type i diabetes mellitus, type ii diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements * currently taking herceptin therapy, or abnormal echo or muga post-herceptin therapy * active tobacco use * currently active in an exercise and/or dietary change weight loss program * if a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.

Keywords: weight loss physical activity dietary change
long-term follow-up study to evaluate the safety and explore the efficacy of multiple doses of furestem-ad inj

Conditions: Atopic Dermatitis

Summary: a multi-center, open, long-term follow-up study to evaluate the safety and explore the efficacy of multiple doses of furestem-ad inj. for moderate to severe chronic atopic dermatitis: 5-year results from the k0104 extension study


Eligibility criteria:
inclusion criteria: 1. subject who enrolled k0104 clinical trial(parent study). 2. subjects who understand and voluntarily sign an informed consent form exclusion criteria: 1. subjects who are expected to be unable to perform at least one follow-up during this study (k0104-e) 2. subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (k0104-e) after the completion of k0104 clinical trial 3. subjects who are judged to be unsuitable for other researchers to participate in the research
to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of inhaled azd7594

Conditions: Safety; Pharmacokinetics; Pharmacodynamics of AZD7594

Summary: the purpose of this study is to evaluate the safety profile and look at levels of azd7594 and biomarkers in blood when the drug is administered inhaled to healthy subjects

a phase i, single centre, double-blind, randomised, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics after single and multiple ascending inhaled doses of azd7594 in healthy male volunteers

Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture * have a body mass index (bmi) between 18 and 30 kg/m2 and weight between 50 and 100 kg (inclusive) * be able to inhale from the spira nebuliser used in the study * be willing to use a condom with spermicide to prevent pregnancy and drug exposure of a female partner exclusion criteria: * history of any clinically significant disease or disorder * current smokers * any clinically relevant abnormal findings

Keywords: phase 1, healthy volunteers, safety, tolerability, pharmacokinetics, pharmacodynamics, single ascending dose study, multiple
development of a new method for analgesia

Conditions: Analgesia

Summary: aim: to examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

a phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). the second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

Eligibility criteria:
inclusion criteria: * patients admitted for adipositas surgery * patients who attend for oesophagogastroduodenoscopy. exclusion criteria: * severe psychiatric diseases * alcohol abuse

Keywords: analgesia tests analog pain scale pain measurement
evaluation of the effects of training at different intensities in coronary artery patients

Conditions: Coronary Heart Disease; Quality of Life; Functional Capacity; Fatigue

Summary: coronary heart disease (chd) remains the leading cause of morbidity and mortality in developed countries, accounting for approximately one-third of all deaths in individuals over 35 years of age. despite research to date, the basis of the disease is still poorly understood, with chronic dysfunction of the autonomic nervous system being proposed as such a basis, as well as pathophysiological and pathogenic approaches. hypertension has been implicated in the development of cardiovascular risk factors such as diabetes and dyslipidaemia and is directly linked to mortality caused by coronary artery disease. moderate intensity continuous training (mict) has been recognised as the gold standard for many years. however, for some time, different researchers have adopted the high-intensity interval training model (hiit) as the most effective method in terms of objective adaptations of most cardiac rehabilitation programmes in patients with coronary artery disease (cad) and congestive heart failure. high-intensity interval training (hiit) consists of cycles between warm-up and cool-down periods, high-intensity exercise intensity followed by an active recovery period. the duration and intensity of these cycles vary between studies and there is no consensus on which is the optimal cycle. in general, the high-intensity exercise phase is applied at 80-100% of vo2 max and the active recovery phase is used between 50-70% of vo2 max. in moderate intensity continuous training the submaximal exercise intensity determined in accordance with the patient's functional capacity between the warm-up and cool-down periods is applied for a fixed period. the moderate intensity continuous training is planned to consist of 20-30 minute sessions between 50-70% of maximum oxygen consumption (vo2max).


Eligibility criteria:
inclusion criteria: * being between the ages of 30 and 65, * being with stable new york heart association functional class i or ii coronary artery disease with angina pectoris or myocardial infarction, * having a left ventricular ejection fraction of 40% or above, * being clinically stable for more than 2 weeks in terms of symptoms and medical treatment. exclusion criteria: * symptoms of ischaemia, * being in class iii-iv according to the new york heart classification, * presence of significant left ventricular outflow obstruction, * ventricular arrhythmia, * significant valvular heart disease, * failure to comply with the rules of exercise testing and training, * significant orthopaedic or neurological comorbidity preventing full participation. * less than 80% participation in the treatment programme * metabolic, haematological or other inflammatory diseases * known psychiatric illness * active malignancy and/or those diagnosed with malignancy within the last 5 years * those who have used tobacco products in the last 5 years * bmi \>35 * history of major orthopaedic surgery within the last 6 months.
improving adherence to pharmacological treatment

Conditions: Medication Adherence

Summary: the overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (chd) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the national cholesterol education program guidelines.

patients were randomly assigned to a usual care condition which consisted of patients provided with usual care only, or to the special intervention (si) condition. the intervention was implemented and coordinated by pharmacists, who utilized for tracking and communication the lotus notes®-based system that was developed for the project.

Eligibility criteria:
inclusion criteria: * was between 30 and 85 years of age; * had known chd, defined as the presence of at least one coronary lesion at coronary angiography of \>50%. exclusion criteria: * was unable or unwilling to give informed consent; * had a history of intolerance to two or more statin drugs; * planned to move out of the area within one year of recruitment; * had a poor prognosis such that life expectancy was thought to be \<5 years; * had a psychiatric illness which limited ability to participate; or * had no telephone.

Keywords: coronary heart disease lipid lowering medication ncep guidelines
mechanocardiography in patients with stemi

Conditions: Myocardial Infarction, Acute

Summary: the study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving st-segment elevation infarction.

subsequent patients with st-segment elevation assigned to the turku university hospital heart center cathlab for primary percutaneous coronary intervention are enrolled in the study. a 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. a control recording is collected after the coronary intervention, within 24 hours. these recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.

Eligibility criteria:
inclusion criteria: * myocardial ischemia with st-segment elevation in ecg * primary pci procedure exclusion criteria: * age \>17 years * no informed consent
chp 834 unrelated and partially matched related donor peripheral stem cell transportation for t and b cell depletion

Conditions: Immunodeficiencies

Summary: this is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (gvhd) in patients receiving unrelated or partially matched related donor peripheral stem cells using the clinimacs system to positively deplete t cells to prevent severe gvhd. feasibility will be tested, focusing on engraftment, treatment-related mortality (with a specific focus on interstitial pneumonitis) and severe gvhd.

primary hypothesis: t cell depletion utilizing the clinimacs device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade iii or iv acute graft vs. host disease (gvhd). secondary hypothesis: use of the clinimacs device will allow defined levels of t cell depletion to reflect the risk of severe gvhd in the donor/recipient pair. thus, patients with a relatively lower risk of severe gvhd will be assigned to stratum 1 and receive a graft with lesser t cell depletion and a defined level of reinfused t cells. patients with higher risk of severe gvhd or for whom there is no perceived clinical benefit of gvhd will be assigned to stratum 2 and receive a more t cell-depleted graft. conditioning of the patient (except immunodeficiencies) includes : * thiotepa 5 mg/kg days for 2 days * cyclophosphamide 60 mg/kg days for 2 days * total body irradiation 200 cgy given twice a day for 3 days following conditioning patient's will receive stem cells that have been processed using the clinimacs device. this processing is done in the stem cell laboratory at the children's hospital of philadelphia. the stem cell lab is accredited by the foundation for the accreditation of cellular therapy (fact) and maintain complete standard operating procedures (sop's) and procedure records. processing of cells using the clinimacs will occur in accordance with the investigator brochure and technical manual following the laboratory sops and using aseptic technique. the chop stem cell lab has extensive prior experience with automated cell processing technologies, including the cellpro ceprate device and the isolex 300i.

Eligibility criteria:
inclusion criteria: as of october 2014 this study closed enrollment to malignant diseases. this study remains open to: non-malignant diseases: 1. bone marrow failure, including severe aplastic anemia 2. immunodeficiencies exclusion criteria: 1. patients who have had prior stem cell transplant (sct) and bone marrow transplant (bmt) are excluded for study enrollment.

Keywords: blood and marrow transplant t cell depletion unrelated related donor
radial versus femoral secondary access during tavi

Conditions: Aortic Stenosis; Aortic Valve Disease; Vascular Access Complication

Summary: the r-tavi study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (tavi).

the r-tavi study is a prospective, single institution, pilot study in which eligible tavi patients will be randomized pre-procedurally to receive either secondary radial artery (ra) access or femoral artery (fa) access during tavi. our study will take place over a projected 18 month enrollment period.

Eligibility criteria:
inclusion criteria: 1) patient meets eligibility for tavr as decided upon by pre-tavr testing (echo, cardiac catheterization, cta tavr, 2 ct surgical consults, heart team discussion). 2) undergoing tavr procedure and follow-up at carilion clinic cardiology roanoke memorial hospital (crmh) 3) patient's secondary vascular access can be performed femorally or radially, as determined by tavr operator after review of pre-tavr ct scan imaging. 4) interventional cardiologist performing the tavr agrees to consider patient for enrollment. 5) patient provides consent 6) age ≥ 18 years old 7) no evidence of precluding arterial disease of both femoral arteries 8) no evidence of precluding arterial disease of right radial and subclavian arteries 9) must have palpable pulses in both radial arteries exclusion criteria: 1. review of pre-tavr ct scan imaging deems patient unsuitable for radial or femoral secondary access based on presence of excessive calcification, stenosis, or tortuosity of the femoral, subclavian, or innominate arteries. 2. valve implantation (primary access) planned via alternative vascular access (trans-caval, axillary, carotid, direct aortic, trans-apical)-as determined by implanting interventional cardiologist/tavr operator. 3. prior coronary artery bypass graft surgery in which a radial artery graft was harvested and used as a conduit. 4. patients on hemodialysis or with arteriovenous fistulas. 5. interventional cardiologist performing the tavr declines patient consideration in the study. 6. patient declines consent. 7. urgent or emergent tavi cases 8. patient is already participating in another clinical research study
the effect of leg cycling exercise program at low or moderate intensity for individuals with subacute stroke

Conditions: Stroke

Summary: poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic. in addition, the poor fitness may obstacle activities of daily life, decrease activities of autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance training should be included into the early-stage rehabilitation program. the ergocycling training could improve cardiopulmonary endurance for individuals with stroke. moreover, the low-intensity exercise training can increase the willingness, and it is safer than the moderate-intensity exercise training. however, it needs to be evaluated whether the low-intensity exercise training can bring sufficient benefits, compared to the moderate-intensity exercise training. objectives of the study is to compare the exercise benefits between the low-intensity and moderate-intensity exercise training, and then these would offer optimal exercise prescription and considerations in clinical practice.

after giving their signed consent, subjects would be randomly assigned into the control group (traditional rehabilitation), the low-intensity exercise group (traditional rehabilitation plus low-intensity exercise training), or the moderate-intensity exercise group (traditional rehabilitation plus the moderate-intensity exercise training). frequency of the exercise training is 2-6 times/week, totally 20 times. in the symptom-limit exercise tolerance tests, subjects wear a gas-collecting mask and electrocardiogram, and pre-set graduated loading was offered by the bike. one therapists and one doctor would monitor the test. for resistance and time setting within each exercise training, it is customized by results of exercise tolerance tests in baseline and the allocation. moreover, a therapist would stay with subject ,monitor the training, and measure the blood pressure before and after the training.

Eligibility criteria:
inclusion criteria: 1. the first-ever stroke 2. period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training 3. unilateral hemiplegia 4. no obvious deficits of cognition. scores of three items in the national institutes of health stroke scale are zero 5. be willing to join this study and give their consent exclusion criteria: 1. aphasia 2. orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently 3. with pace maker, severe cardiac arrhythmia, or heart failure 4. abnormal electrocardiography in rest, is not suitable for exercise tolerance test according to the american college of sports medicine guidance, for example, the atrioventricular block (av block).

Keywords: stroke exercise capacity
immune response following covid-19 vaccination

Conditions: IgM and IgG in Blood

Summary: few trials have reported the safety and efficacy of the covid-19 vaccines. however, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin g (igg) in blood at long-term follow-up after the vaccination. this study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.

the covid-19 pandemic started in december 2019 and since then has spread globally claiming over 550, 000 deaths, \>12 million infections and an economic toll in the trillions of dollars to date. the urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines. preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4). however, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine. therefore, this study is designed to assess the presence of immunoglobulin (ig) m and g at several time points after the first and the second dose of the vaccine.

Eligibility criteria:
inclusion criteria: • individuals that have received first dose of covid-19 vaccine exclusion criteria: * unwilling to provide informed consent * unwilling for the follow-up serological test during the 1-year enrollment
factors affecting adherence to anti-hiv drug regimens in children and adolescents

Conditions: HIV Infections

Summary: taking anti-hiv medication consistently and properly is a critical issue for patients with hiv. drug regimens are complex; when regimens are not taken properly, hiv can become resistant to the drugs. taking anti-hiv medication properly leads to improved health. children and adolescents with hiv face unique challenges to taking hiv medication properly. this study will look at the relationship between how children cope with the responsibility for taking medication and the child's language, memory, attention, behavior, and academic skills. this study is open to children and adolescents who are currently enrolled in the pactg 219c study (long-term effects of hiv exposure and infection in children).

medication adherence is a critical issue for hiv infected children and adolescents because of drug resistance and the increased complexity of treatment regimens. children and adolescents with hiv face depression, anxiety, denial, and rebellion that may interfere with their motivation to take medication. depression and self-perceived social support have been found to predict regimen adherence in adults with hiv. children with other chronic diseases are less likely to adhere to their medication regimens if they also have behavioral or emotional problems; assessing emotional and behavioral function in children and adolescents with hiv may help in predicting adherence and explaining adherence failure. this study will correlate cognitive, behavioral, and psychosocial functioning with measures of virologic suppression and immunological status, and it will compare self-report and pill count measures of adherence in a randomly selected subset of perinatally infected hiv participants of pactg 219c. children and adolescents currently enrolled in pactg 219c will be randomly selected for this study, which will last for 48 weeks. at entry, participants will undergo neuropsychological evaluation, including academic achievement, attention, memory, language comprehension, and behavior assessments, and complete a health beliefs questionnaire. both the participants and their parents or primary caregivers will complete questionnaires at study entry and weeks 24 and 48. adherence will be evaluated from self-reported and pill count measures (weeks 4 and 24) and the pactg 219c adherence module (weeks 24 and 48).

Eligibility criteria:
inclusion criteria * hiv-1 perinatal infection * already enrolled and in active follow-up in pactg 219c * can communicate in english or spanish * on antiretroviral medication regimen at the time of enrollment, regardless of compliance with regimen, with no planned treatment interruptions exclusion criteria * acquired hiv via routes other than perinatal transmission or source of hiv infection is unknown * hiv-2 infection

Keywords: treatment experienced